four pages)------------------------------------------------ 6 Other Biographical Sketch-- (Not to exceed four pages for each -- (See instructions)------------------------------------------------------ 9 Resources-------------------------------------------------------------------------------------------------------------------------------------------------------- 16 Research Plan 18 A. Specific Aims------------------------------------------------------------------------------------------------------------------------------------ 18 B. Background and Significance-------------------------------------------------------------------------------------------------------------- 19 C. Preliminary Studies/Progress Report/ (Items A-D: not to exceed 25 pages*) 22 Phase I Progress Report (SBIR/STTR Phase II ONLY) *SBIR/STTR Phase I: Items A-D limited to 15 pages. D. Research Design and Methods------------------------------------------------------------------------------------------------------------ 33 E. Human Subjects-------------------------------------------------------------------------------------------------------------------------------- Protection of Human Subjects (Required if Item 4 on the Face Page is marked "Yes") Inclusion of Women (Required if Item 4 on the Face Page is marked "Yes")---------------------------------------------------- Inclusion of Minorities (Required if Item 4 on the Face Page is marked "Yes")-------------------------------------------------- Inclusion of Children (Required if Item 4 on the Face Page is marked "Yes")---------------------------------------------------- Data and Safety Monitoring Plan (Required if Item 4 on the Face Page is marked "yes" and a Phase I, II, or III clinical trial is proposed) F. Vertebrate Animals---------------------------------------------------------------------------------------------------------------------------- 43 G. Literature---------------------------------------------------------------------------------------------------------------------------------------- 44 H. Consortium/Contractual Arrangements-------------------------------------------------------------------------------------------------- I. Letters of Support (e.g., Consultants)------------------------------------------------------------------------------------------------------ 50 J. Product Development Plan (SBIR/STTR Phase II and Fast-Track ONLY)------------------------------------------------------ Checklist---------------------------------------------------------------------------------------------------------------------------------------------------------- 54 Appendix (Five collated sets: No page numbering necessary for Appendix.) Check if Appendix is Appendices NOT PERMITTED for Phase I SBIR/STTR unless specifically solicited. Included Number of publications and manuscripts accepted for publication (not to exceed 10) Other items (list): PHS 398 (Rev. 05/01) Page 4